The present invention is generally in the field of pharmaceutical compositions, and specifically relates to compositions that are designed to deter dosage form splitting and prevent improper administration of medications and adverse effects resulting from administration of inadequate or therapeutically inappropriate doses of a medication, immediately (i.e., in a single dose) and over time (i.e., with multiple doses). The present invention can comprise any drug. More specifically, it pertains to any drug of which patients could benefit from accurate dosage administration. It is also particularly useful to minimize the risk of medication overdose or suboptimal therapy, and adverse effects from excessive drug levels or from ineffective treatment of conditions due to inadequate blood concentrations of a medication.
In particular, the present invention relates to a pharmaceutical composition configured to deter dosage form splitting and use of such a composition in a dosage form to treat diseases or conditions while minimizing the risk of adverse effects from improper or irregular concentrations of drug in the blood due to dosage form splitting.
Dosage form splitting, also sometimes called tablet splitting or pill splitting, refers to the practice of modifying a dosage form to obtain a lower dose of an active ingredient, or to obtain multiple smaller doses by dividing the dosage form into multiple pieces. Dosage form splitting typically involves oral dosage forms such as tablets or caplets, but can involve any monolithic pharmaceutical dosage forms. Dosage form splitting is accomplished typically by cutting or chopping the dosage form, but it can be accomplished by any means which allow the dosage form to be divided into multiple pieces. For example, the dosage form can be cut or chopped into multiple pieces with a sharp object such as a knife, split into pieces by breaking the dosage form with one's hands or even biting down on the dosage form with one's teeth. Dosage form splitting is often accomplished by means of a tablet splitter or pill splitter, which is a device comprising a means for holding the dosage form in place, and a blade which is pressed down to spit the dosage form.
In some cases, dosage forms are meant to be split and are scored so that a patient can easily divide the dosage form into multiple pieces. However, for many medications, it is unsafe to split a dosage form. Unless scored to facilitate splitting, split dosage forms are typically uneven and the amount per dose can vary dramatically. Some pharmaceutical compositions are extremely hard and require significant force to split. Other compositions are soft and crumble into a powder when split.
Variations in a patient's blood levels resulting from inconsistent dosages can result in adverse effects, such as suboptimal treatment of conditions or the buildup of toxic drug levels due to excessive doses of drug in the split dosage forms. Some medications require precise and consistent doses, such as cardiac medications or hormones. For example, patients taking anticoagulants such as warfarin, or hormones such as lexothyroxine, benefit from consistent, accurate dosages of the drugs.
It is an object of the present invention to provide a pharmaceutical composition that significantly reduces the potential for improper administration of medication and adverse effects resulting from administration of inadequate or therapeutically inappropriate doses of medication.